Read and answer the question : On June 25, 2015, Lee Pharma Limited filed an application with the Indian Patent Office for a grant of a compulsory licence for the manufacturing of Saxagliptin, an already patented drug covered under patent No. 206543. Lee Pharma based its request on the grounds that the patented invention had not been made available to the public at a reasonably affordable price (see Exhibit 1).2 Lee Pharma's was the third such application for a compulsory licence received by the Indian Patent Office since the country had amended its Patents Act in 20053 to meet the compliance requirement of the multilateral Agreement on TradeRelated Aspects of Intellectual Property Rights (TRIPS)4 established by the World Trade Organization (WTO). The granting of a compulsory licence was expected to make the drug more affordable for the general public, but it would have the corresponding effect of undermining the interests of the patentee, a multinational company that originated from the developed world. If the developed world imposed sanctions against India in retaliation for such a protectionist measurewhich the compulsory licence certainly wasthe flow of trade and foreign capital into the country would be adversely affected. What should the patent office do? Should it strictly enforce the patent regime, which would encourage higher foreign capital inflows in research and development (R&D) in the Indian pharmaceutical industry and promote inventions and inventions and innovations in the country? Or should it grant the compulsory licence, thereby attaching higher weight to the welfare of India's general public? SAXAGLIPTIN: ORIGIN AND DEVELOPMENT Saxagliptin was a dipeptidyl peptidase-4 inhibitor used for lowering blood sugar levels in type 2 diabetes,5 a condition of high blood-sugar levels in the human body that occurred when the body did not produce or use enough insulin in the pancreas. Other comparable drugs (e.g., Sitagliptin, Vildaglipt

WORLD TRADE ORGANIZATION: AGREEMENT ON TRADE-RELATED INTELLECTUAL PROPERTY RIGHTS AND COMPULSORY LICENSING As a multilateral organization with 162 member countries,18 the WTO was established in January 1995 to ensure the free flow of goods and services among nations. The organization created a smooth, predictable, and conducive trade environment by eliminating or moderating tariff and non-tariff barriers.19 The WTO was a very powerful body due to the fact that the rules set by this platform

INDIAN PHARMACEUTICAL INDUSTRY: PERFORMANCE, PRICING POLICY, AND PATENT REGIME Performance In the fiscal year ending March 2015, the Indian pharmaceutical industry recorded revenues of over $30 billion.27 Accounting for around 10 per cent of global production volume and 1.5 per cent of global production value, the Indian Pharma Market (IPM) was among the world's top three pharmaceutical markets in terms of volume and 14th largest in terms of value.28 It was projected to grow to $55 billion by 20

COMPULSORY LICENSING IN INDIA The WTO included a provision for compulsory licensing in its TRIPS agreement to safeguard the interest of the general public in developing and least-developed countries.50 This provision enabled the governments of these countries to grant a licence to domestic manufacturers to produce a patented drug without seeking the patent holder's consent. Instead, domestic manufacturers in these countries were required to make appropriate compensation to the patent holder,

WHAT SHOULD BE CONSIDERED MOST IMPORTANT: INNOVATIONS OR SOCIAL WELFARE? The late American pharmaceutical-manufacturing executive George Merck once stated, "We try never to forget that medicine is for the people. It is not for the profits."64 In keeping with that ideal, the patent controller's grant of a compulsory licence to Lee Pharma for Saxagliptin would certainly address the public welfare concern in India, and it would also break the monopoly of multinational giants and spur competition

EXHIBIT 1: GLOSSARY OF KEY TERMS Term Meaning Branded Drug A branded drug is the drug available in the market by the name that is assigned to it by the manufacturer. Bulk Drug A bulk drug, also known as an "active pharmaceutical ingredient," is the chemical molecule that determines the claimed therapeutic effect of a given medicine. In the absence of a bulk drug, the drug is not considered to be a medicine. Formulation A formulation is the medicine we buy in the market in the form of a tablet, c

EXHIBIT 2: PRICE OF SORAFENIB (NEXAVAR) BY COUNTRY Country Date of Quote Price of One Tab in U.S. Dollars Australia Feb. 10, 2012 57.60 Belgium Feb. 13, 2012 44.75 Canada Feb. 15, 2012 63.53 Czech Republic Feb. 13, 2012 44.48 Denmark Feb. 13, 2012 55.93 India (Bayer) Feb. 11, 2012 46.97 India (CIPLA) Feb. 11, 2012 4.68 Norway Feb. 13, 2012 61.05 Slovakia Feb. 13, 2012 45.45 Spain Feb. 10, 2012 42.59 Sweden Feb. 10, 2012 47.32 South Africa Feb. 28, 2012 40.06 United States Feb. 10, 2012 84.07

EXHIBIT 3: TOP 15 EXPORTERS AND IMPORTERS OF PHARMACEUTICAL PRODUCTS IN THE WORLD IN 2014 Country Export Share Rank Country Import Share Rank Germany 14.57 1 United States 13.52 1 Switzerland 12.19 2 Germany 8.85 2 Belgium 9.64 3 Belgium 7.54 3 United States 8.84 4 France 5.74 4 France 6.52 5 United Kingdom 5.73 5 United Kingdom 6.29 6 Switzerland 4.45 6 Ireland 5.36 7 Italy 4.35 7 Netherlands 4.99 8 Netherlands 3.73 8 Italy 4.81 9 Japan 3.68 9 Spain 2.46 10 China 3.36 10 China 2.43 11 Spain 2.8 :

After you read discus what COMPULSORY LICENCE FOR SAXAGLIPTIN: PROTECTION VERSUS COMPETITION.